Grand Opening of New Medical Grade Silicones Facility

Designed to produce high purity silicone materials that meet the MedTech and Pharma market requirements, this new 18,000 sq.ft. site features state-of-the-art ISO-certified Class 7 and Class 8 clean rooms. 

Operations at this site are controlled under one quality management system that meets the requirements of ISO 9001, ISO 13485 and IPEC Good Manufacturing Practice (GMP) guidelines.  

“Elkem’s investment in this highly specialized facility demonstrates our commitment to growing with our customers around the world in medical implantable and pharmaceutical applications,” said Bertrand Mollet, president of Elkem Silicones Americas. “As the only fully integrated silicone supplier in this space, we are incredibly proud of this facility and all the opportunities it offers our customers.”

“Now, customers have a choice in their partner for quality medical grade silicones,” adds Bob Waitt, global strategic marketing director of Elkem’s Life Sciences.  “This is another example of Elkem’s commitment to raising the bar for what customers should come to expect of their silicone partner.  Whether addressing supply security risks or next generation device development, we now have a world class manufacturing infrastucture to combine with our comprehensive implant grade product range and global technical & regulatory support network to meet critical market needs. This is good news for our customers and, most importantly, patient care.”

Serving as Elkem’s global center of excellence for medical grade silicones, the company produces medical grade liquid silicone rubber (LSR), high consistency rubber (HCR), high purity silicone gels, silicone adhesives and dispersions marketed under the Silbione® Biomedical brand in this highly controlled environment in York.  Elkem’s Silbione® Biomedical products are supported by Master Access Files (MAF), and where applicable Drug Master Files (DMF), filed with the U.S. Food and Drug Administration (FDA). 

Located on Timberland Court, this new facility is Elkem’s second operational facility in York.  In 2012, the company opened its main manufacturing campus for North America on Park Place Rd., which is located a half mile from the new facility.

Elkem’s commitment to Sustainability

All known technological solutions for the green transition require advanced materials.  Silicones, silicon and carbon solutions are critical enablers and this is one of the most significant ways for Elkem to have an impact; by ensuring durable and sustainable supply to the green transition towards a low carbon future.

Elkem is committed to take a leading position in reducing the impacts of climate change. Elkem's ambition is to reduce the company's fossil CO₂ footprint by increasing renewable carbon sources and developing innovative production processes. With a fully integrated value chain from upstream silicon to silicones and their downstream uses, it is vital to manage the environmental production footprint.

Elkem continues to prove leadership in sustainability and climate reporting transparency confirmed with our Platinum rating on Ecovadis and A- rating on CDP Climate.

Read more about Sustainability

About Elkem ASA

Elkem is one of the world’s leading providers of advanced material solutions shaping a better and more sustainable future. The company develops silicones, silicon products and carbon solutions by combining natural raw materials, renewable energy and human ingenuity. Elkem helps its customers create and improve essential innovations like electric mobility, digital communications, health and personal care as well as smarter and more sustainable cities. With a strong track record since 1904, its global team of more than 7,000 people has a joint commitment to stakeholders: Delivering your potential. In 2021, Elkem was rated among the world’s leading companies on climate, with a roadmap towards net zero emissions by 2050, and achieved an operating income of NOK 33.7 billion. Elkem is listed on the Oslo Stock Exchange (ticker: ELK).